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History of Changes for Study: NCT02349061
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
Latest version (submitted March 11, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 23, 2015 None (earliest Version on record)
2 May 1, 2015 Arms and Interventions, Study Status, Outcome Measures and Contacts/Locations
3 June 3, 2015 Study Status and Eligibility
4 June 25, 2015 Study Status and Contacts/Locations
5 July 16, 2015 Study Status and Contacts/Locations
6 August 7, 2015 Study Status and Contacts/Locations
7 August 21, 2015 Study Status
8 September 23, 2015 Contacts/Locations, Study Status and Oversight
9 October 16, 2015 Study Status
10 October 27, 2015 Recruitment Status, Contacts/Locations and Study Status
11 November 19, 2015 Contacts/Locations and Study Status
12 December 21, 2015 Contacts/Locations, Arms and Interventions, Study Status, Eligibility and Outcome Measures
13 January 12, 2016 Contacts/Locations and Study Status
14 February 2, 2016 Study Status and Contacts/Locations
15 February 23, 2016 Contacts/Locations and Study Status
16 March 15, 2016 Contacts/Locations and Study Status
17 April 5, 2016 Contacts/Locations and Study Status
18 April 22, 2016 Contacts/Locations and Study Status
19 May 13, 2016 Study Status and Contacts/Locations
20 June 1, 2016 Study Status and Contacts/Locations
21 June 22, 2016 Contacts/Locations and Study Status
22 July 13, 2016 Study Status and Contacts/Locations
23 August 3, 2016 Contacts/Locations and Study Status
24 October 14, 2016 Contacts/Locations, Study Status and Study Identification
25 November 11, 2016 Study Status and Contacts/Locations
26 December 9, 2016 Contacts/Locations and Study Status
27 January 6, 2017 Study Status and Contacts/Locations
28 February 17, 2017 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions, Study Design and Conditions
29 March 9, 2017 Study Status
30 April 20, 2017 Contacts/Locations, Study Status and Oversight
31 May 16, 2017 Study Status
32 June 16, 2017 Study Status
33 July 11, 2017 Study Status
34 August 8, 2017 Recruitment Status, Contacts/Locations, Study Status and Study Design
35 September 5, 2017 Recruitment Status, Contacts/Locations, Study Status and Study Design
36 May 15, 2018 Study Status, Contacts/Locations, Outcome Measures, Document Section and Results
37 August 8, 2018 Study Status
38 October 3, 2018 Study Status
39 October 31, 2018 Study Status
40 December 27, 2018 Study Status
41 February 21, 2019 Study Status
42 March 28, 2019 Recruitment Status, Study Status and Contacts/Locations
43 March 11, 2020 Adverse Events, Participant Flow, Outcome Measures, Baseline Characteristics, Study Status
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Study NCT02349061
Submitted Date:  January 23, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR106661
Brief Title: A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Secondary IDs: CNTO1275SLE2001 [Janssen Research & Development, LLC]
Open or close this module Study Status
Record Verification: January 2015
Overall Status: Not yet recruiting
Study Start: April 2015
Primary Completion: November 2016 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: January 23, 2015
First Submitted that
Met QC Criteria:
January 23, 2015
First Posted: January 28, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 23, 2015
Last Update Posted: January 28, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Research & Development, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis, kidney problems, and anemia, among other problems).
Detailed Description: A multicenter (more than one medical research center involved in study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study drug), placebo-controlled, proof-of-concept study of ustekinumab in participants with active systemic lupus erythematosus. Participants will be screened to achieve all inclusion criteria and none exclusion criteria and will then receive either ustekinumab or placebo along with concomitant background medicine. Participants will be primarily assessed for response using the Systemic Lupus Erythematosus Response Index 2000 (SRI-4). Participants' safety will be assessed throughout the study.
Open or close this module Conditions
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Ustekinumab
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1
Participants will receive weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0 followed by ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40. Participants will maintain stable concomitant treatment through Week 48, with safety follow-up through Week 56.
Drug: Ustekinumab
Participants will receive weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0 followed by ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40. Participants will maintain stable concomitant treatment through Week 48, with safety follow-up through Week 56.
Other Names:
  • STELARA
Drug: Placebo
Participants will receive placebo intravenously at Week 0 followed by placebo subcutaneously at Weeks 8 and 16 to Group 2. At week 24 participants will receive ustekinumab subcutaneously at every 8 weeks up to Week 40 to Group 1.
Concomitant Medication
Participants are to maintain stable concomitant treatment (azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, anti-hypertensive medications, and topical medications) through Week 48, with safety follow-up through Week 56.
Experimental: Group 2
Participants will receive placebo intravenously at Week 0 followed by placebo subcutaneously at Weeks 8 and 16. At Week 24 participants will cross-over and will receive ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40. Participants will maintain stable concomitant treatment through Week 48, with safety follow-up through Week 56.
Drug: Ustekinumab
Participants will receive weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0 followed by ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40. Participants will maintain stable concomitant treatment through Week 48, with safety follow-up through Week 56.
Other Names:
  • STELARA
Drug: Placebo
Participants will receive placebo intravenously at Week 0 followed by placebo subcutaneously at Weeks 8 and 16 to Group 2. At week 24 participants will receive ustekinumab subcutaneously at every 8 weeks up to Week 40 to Group 1.
Concomitant Medication
Participants are to maintain stable concomitant treatment (azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, anti-hypertensive medications, and topical medications) through Week 48, with safety follow-up through Week 56.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants With a Composite SRI-4 Response at Week 24
[ Time Frame: Week 24 ]

Systemic Lupus Erythematosus Responder index (SRI-4) is defined as greater than or equal to (>=) 4 point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, no new domain scores in either British Isles Lupus Assessment Group (BILAG) A or B and no worsening (less than [˂] 10 millimeters [mm] increase) from baseline in the Physician's Global Assessment of Disease Activity (PGA). The SLEDAI - 2k assessment consists of 24 items which has total score of 0 to 105, with higher scores representing increased disease activity. The BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 8 organ systems. For each organ system, letter score was given: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale (VAS) = from 'very well' (0) to 'very poor' (10).
Secondary Outcome Measures:
1. Change From Baseline in SLEDAI-2K Score at Week 24
[ Time Frame: Week 24 ]

Systemic lupus erythematosus disease activity index 2000 (SLEDAI - 2k) assessment consists of 24 items. A weighted score of 8, 4, 2, and 1 were assigned for items 1 to 8, items 9 to 14, items 15 to 21, and items 22 to 24, respectively. A SLEDAI global score for Systemic lupus erythematosus (SLE) disease activity was derived by adding all weighted scores. Total possible score range for SLEDAI - 2K global score is 0 to 105, with higher scores representing increased disease activity.
2. Change From Baseline in Physician Global Assessment of Disease Activity (PGA) at Week 24
[ Time Frame: Week 24 ]

The Physician Global Assessment of Disease Activity will be recorded on a visual analogue scale (VAS = 0 to 10 centimeters [cm]). The scale for the assessments range from 'no lupus activity' (0) to 'extremely active lupus' (10).
3. Percentage of Participants With BICLA Response at Week 24
[ Time Frame: Week 24 ]

The BILAG-based Combined Lupus Assessment (BICLA) requires participants to meet response criteria across 3 assessment tools and no treatment failure must be recorded: 1) BILAG improvement classified as: a) All BILAG A scores at baseline improved to either BILAG B, C or D b) All BILAG B scores at baseline improved to either BILAG C or D, c) No worsening in disease activity defined as no new BILAG A scores and <= 1 new BILAG B score. 2) No worsening of total SLEDAI-2K from baseline (change <= 0). 3) No significant deterioration (<10 mm increase) in 100 mm visual analogue PGA scale.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Subjects must have documented medical history to meet SLICC classification criteria for SLE for a minimum of 3 months prior to first dose
  • At least 1 well-documented (subject file, referring physician letter, or laboratory result), unequivocally positive, test for autoantibodies in medical history including either of the following: ANA, and/or anti-dsDNA antibodies, and/or anti-Smith antibodies
  • At least 1 unequivocally positive autoantibody test including ANA and/or anti-dsDNA antibodies and/or anti-Smith antibodies detected during screening
  • At least 1 BILAG A and/or 2 BILAG B domain scores observed at screening and/or at Week 0 prior to first administration of study agent
  • Demonstrate active disease based on SLEDAI-2K score greater than or equal to (>=) 6 observed during screening and assessed approximately 2 to 6 weeks prior to randomization (Week 0). Must also have SLEDAI-2K score >= 4 for clinical features (ie, SLEDAI excluding laboratory-based items) at Week 0 prior to the first administration of study agent

Exclusion Criteria:

  • Have other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis or Lyme disease
  • Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent
  • Have received systemic immunosuppressives other than those described in inclusion criteria within the past 6 months prior to first administration of study agent (Section 4.1).
  • Have received more than 1 previous B cell targeting therapy including belimumab or epratuzamab within 6 months prior to first administration of the study agent or received B-cell depleting therapy (eg, rituximab) within 12 months prior to first administration of the study agent or have evidence of continued B-cell depletion following such therapy
  • Have ever received ustekinumab
Open or close this module Contacts/Locations
Central Contact Person: This study is not yet recruiting patients. Please check back for future recruiting sites, or email
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Locations: United States, Oregon
Portland, Oregon, United States
United States, Tennessee
Jackson, Tennessee, United States
United States, Utah
Salt Lake City, Utah, United States
Australia
Queensland, Australia
Sydney, Australia
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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